68Ga-PSMA PET/CT or PET/MRI in Evaluating Patients With Recurrent Prostate Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-08-31

Brief Summary

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This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys\[Ahx\]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.

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Detailed Description

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PRIMARY OBJECTIVES:

Evaluate the feasibility and biodistribution of 68Ga-PSMA.

OUTLINE:

Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45 to 60 minutes later.

After completion of study, patients are followed up at 24 hours and 1 week.

Conditions

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Recurrent Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (68Ga-PSMA PET/CT or PET/MRI)

Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Part of PET/CT scan

Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)

Intervention Type DRUG

Intravenously-administered (IV) radioisotope

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Part of PET/MRI scan

Positron Emission Tomography

Intervention Type PROCEDURE

Part of PET/CT and/or PET/MRI scans

Interventions

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Computed Tomography

Part of PET/CT scan

Intervention Type PROCEDURE

Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)

Intravenously-administered (IV) radioisotope

Intervention Type DRUG

Magnetic Resonance Imaging

Part of PET/MRI scan

Intervention Type PROCEDURE

Positron Emission Tomography

Part of PET/CT and/or PET/MRI scans

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT SCAN tomography (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC 68Ga-HBED-CC-PSMA ProstaMedix Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Medical Imaging, Positron Emission Tomography PET PET SCAN Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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Inclusion Criteria

* Provides written informed consent
* Known diagnosis of prostate cancer
* Patient has suspected recurrence based on biochemical data (prostate specific antigen \[PSA\] \> 2 ng/mL)
* Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria

* Unable to provide informed consent
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No